EUCTR2011-000708-17-HU进行中（未招募）不适用
A 24 months, prospective, randomized, double-blind study to assess the effect of daily oral administration of 2 g of strontium ranelate versus placebo on bone mineral density in postmenopausal osteoporotic women previously treated with bisphosphonates
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Postmenopausal women, aged > or = 50 years
- •- Osteroporotic patients at high risk for fracture previously treated by bisphosphonate for at least 30 months among the last 5 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •- Patients with at least one of the following DXA related criteria in reference to the lowest BMD value at any relevant site (L1-4, total hip, femoral neck):= -4.0 SD T-score, > -1.5 SD T-score in patients with prevalent osteoporotic fractures, > -2.0 SD T-score in patients without prevalent osteoporotic fractures
- •- Patients with two or more clinical osteoporotic fractures within the last 3 years
- •- Current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
- •- Current or previous venous thromboembolism events, including deep vein thrombosis and pulmonary embolism, or patients at high risk of venous thromboembolism.
- •- Temporary or permanent immobilzation due to e.g. post-surgical recovery or prolonged bed rest.
- •- BMI <18 or > 32 kg/m²
- •- Skeletal disease other than primary osteoporosis
- •- Sarcoidosis
- •- Phenylketonuria
- •- Hypersensitivity to the active substance or to any of the excipients, hypersensitivity to soy or peanuts
- •- Hereditary fructose intolerance, glucose-galactose malabsorption, saccharase isomaltase deficiency
- •- Severe renal insufficiency
研究者
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